Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple
Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients
What it found
We found no results in the registry or in papers.
This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)
What it measured
Main measures
Discrimination of walking disorder status
Day 0
Walking and mobility
Other measures (21)
Foot tapping test
day 0
Finger tapping test
day 0
Arm and hand functionHeel-knee test
day 0
Romberg test
day 0
Walking and mobilityFinger to nose test
day 0
Arm and hand functionTimed 25 foot walk test result
day 0
Disability progressionWalking and mobilityNine holes peg test
day 0
Arm and hand functionExpanded disability status scores (EDSS)
Day 0 and at one year
Disability progressionWalking and mobilityPatient-reported disability using self-report questionnaire
Day 0 and at one year
Quality of life (reported by participants)Twelve items Multiple Sclerosis Walking Scale Assessment (MSWS-12) scale
Day 0 and at one year
Walking and mobility
Who could take part
Relapsing and progressive · 18 to 64
Show the full criteria
Inclusion criteria
* Aged between 18 to 64 years inclusive (Patients over 64 years will not be enrolled to avoid possible effect of aging on the voluntary movement assessed); * Confirmed diagnosis of MS according to the revised McDonald criteria (including primary progressive, secondary progressive and relapsing-remitting MS) with brain lesions consistent with MS if data available; * No history of relapse in the previous 5 weeks. * Must be able or think they are able to attempt both finger and foot tapping tests, F2NT, 9HPT and be ambulatory with or without assistance.
Exclusion criteria
* Pregnant women * Minors * Adults under guardianship * Adults over 64 years
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing the extent of multiple domains of MS-related disability is critical for effective clinical care and the development of new paradigms for patient-focused therapeutic approaches. To date outcomes research in MS has centered on clinical exams, which may be insensitive over the short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot of the patient's performance. With the mass production of sensors in the gaming and computer control industry, there is an opportunity to transform the traditional neurological exam with biosensors already in use outside the realm of health applications. The investigators herein propose to use a commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators will determine if the device can differentiate the diseased states, refine signal processing algorithms to create reliable outcomes using this device in MS patients, and determine if these outcomes are strongly associated with patients and physicians reported ambulatory and dexterity metrics. The investigators hypothesize that this digital technology may be introduced in the standard neurological exam technique in a non-disruptive manner and more accurately and potentially remotely detect both physician-reported and patient-reported disability. In the scope of this study, the investigators will also develop signal processing methodology to comprehensively track ambulation features.
Loading reviews and guidelines…
History
Started
Jan 2018
Main results due
Feb 2020
Finished
Feb 2020